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Job #02970

About our client Our client is a privately owned company developing minimally invasive solutions for the diagnosis, treatment and follow-up of breast diseases. They have a strong management team and an innovative pipeline. This is a great opportunity for the right candidate! Position Location Quality Assurance Director Northeastern USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure quality management system compliance with all applicable domestic FDA/overseas quality system regulations 2) Update quality system procedures to maintain compliance and continual quality system improvements 3) Manage all aspects of internal quality system audits 4) Analyze and track trends of the key quality system metric (on an on-going basis) 5) Manage implementation, support and maintenance of company-wide quality objectives as well as goals 6) Coordinate scheduled management review meetings with senior management and host external FDA/QSIT inspections 7) Manage customer complaints and ensure timely as well as appropriate market feedback, complaint evaluation and complaint resolution 8) Develop GMP training materials and conduct training sessions for quality system procedures 9) Participate in product development and design control/improvement project activities, including risk management and product/process validation Requirements 1) Bachelor's/advanced degree in Engineering or any other Biomedical discipline 2) 4+ years of experience in quality assurance/quality engineering 3) Previous experience of managing overseas staff in India 4) Team leadership experience and project-management skills a plus 5) Excellent communication skills (verbal and written)